"It depends upon what the meaning of the word 'is' is." ~ Bill Clinton
I recently came across a rather humorous document from a legal action that was taken way back in 2008 against the drug company giant AstraZenica (AZ) in litigation over marketing issues with its antipsychotic drug, Seroquel (Quetiapine). I thought it would be fun to share with my readers.
It came from the United States District Court, Middle District of Florida, Orlando division in the matter of Seroquel products liability litigation, Case # 6:06-md-01769-ACC-DAB, on April 24, 2008.
It was a Q&A between a lawyer and the AZ executive who was involved in organizing the slides used in promotional talks given to physicians. It concerned the use of the term "unsurpassed" in slides used to market the drug.
Seroquel was one of the newer "atypical" antipsychotic medications. They were called that to distinguish them from the old, "typical" antipsychotics like Haldol. The old drugs were notorious for causing acute neurological side effects such as a Parkinson's disease-like tremors and muscle spasms (which can be easily countered with another class of drugs), as well as a long term one called tardive dyskinesia (TD) that could become permanent.
To see what TD looks like, watch the Batman Movie The Dark Knight with Heath Ledger playing the Joker, who I guess was supposed to have been an ex mental patient, and was portrayed as having the mouth movements typical of TD.
The new '"atypical" drugs are much less likely to cause these neurological problems, but instead are far more likely to cause metabolic syndrome - weight gain, increased cholesterol, and even diabetes. (Recently released ones in the last few years are better on this score as well, but Seroquel is one of the worst offenders in this regard). Pick your poison. Atypicals have never been shown to be more effective than the typicals for the hallucinations and delusions characteristic of psychotic disorders.
In fact, AZ's own documents showed that the company analyzed 10 studies, and found that none of them showed that Seroquel was superior to any other antipsychotic drug.
So how did AZ spin this in its sales presentation to doctors? Their slides said the drug was "unsurpassed" in efficacy the treatment of schizophrenia. They found that this word was one that worked.
This is funny because there are two different definitions of "unsurpassed." The definition most people think of is "superior in achievement or excellence to any other." In other words, most people would think that the slide indicated that Seroquel was the most effective antipsychotic drug available.
The more literal definition, however, is "as good as or better than any other." This means that other drugs can be equally as good. Obviously, that wasn't the message that the slides were meant to convey to the doctors, but because the lesser known definition exists, this gave the company plausible deniability against the charge that it was making claims unsubstantiated by any research - even though that was the take home message most people would take home. Pretty sneaky!
The company man responded to questions about this with mental sommersaults, some of which - as my friend Peter Parry points out - are cringe-worthy. So here it is (minus some objections by the involved lawyers):
Q. Let me just read the conclusion to the jury and then ask you a question about it. "Conclusions. The intended claim of 'superiority versus Haloperidol' is highly unlikely using these data, however 'a claim of equivalence is not ruled out.' Did I read that correctly?
A. Yes, you did.
Q. Were you ever informed of that Technical Document No. 5 or its conclusions?
A. I have told you twice already no.
Q. Okay. Do you think you maybe should have been informed of this information before you Went around making claims of unsurpassed efficacy?
A. No, because I took my guidance from the head of clinical, the disclosure committee, and the SERM group. By the way, how is
equivalence different from unsurpassed?
Q. Do you really think you get to ask me questions? Is that what you think this process involves, that you get to ask me questions and I give you answers?
A: I'm trying to answer your question.
Q. Well, let me ask, since you asked me a question, let me ask you a
question: "Unsurpassed," "unsurpassed,"- what does that mean?
A. It means --
Q. Nobody is better; right?
A. It means equivalent.
Q. So if I really -- I'm trying to think of something. If I tell
somebody that I went to a track meet and I saw an athlete that has been
unsurpassed, I mean he was -- her, let's say her. Her ability to do the broad jump and the high jump and the relays were unsurpassed, and I was just so impressed and I go and tell you it was unsurpassed, you believe that means I'm saying she was equivalent to everybody else at the meet?
A. Possibly, yes. That's the correct grammar. Possibly, yes. She
was possibly better; she was possibly equivalent.
Q. And if I come home and --your child, you said, is 5 years old?
A. I have got two.
Q. How old are they? Mine are 22, 20, and 17. How old are yours?
A. 3 and 5.
Q. When your child comes home from school let's say from first grade
and says, "Daddy, I" -- well, I don't think first grade. And your child may be smart because you are smart. So let's just go to fifth grade. Go to
fifth grade. "Daddy, my grade in my English class was unsurpassed." What
are you going to say, "Congratulations.You made the same grade as everybody else"? Is that what you are telling this jury, is "unsurpassed" means the same?
A. Yes, it does, it means the same as or better. That's exactly what it means.
Q. So -- that's exactly what it means. So when AstraZeneca -- I'm glad to know this. This is interesting and I'm glad we're getting this out here. So when AstraZeneca made the claims of unsurpassed efficacy in regard to Seroquel, what they were meaning to say was, "We are just the same as everybody else"; is that right?
A. No, but I think we were incredibly careful with the use of grammar to depict what the clinical studies showed and concluded.
Q. You were trying to be tricky?
A. No. We were being incredibly precise and using the correct language. Of course, the language varied from country to country and label to label. The global impression from the safety and efficacy review group was our efficacy was unsurpassed.
Q. And you said in order to use that language, using your words, you were being incredibly careful; is that right?
A. No, I didn't. I said "incredibly precise."
Q. "Incredibly precise"; is that right?
A. Yes.
Q. All right. So if somebody understood the term "unsurpassed efficacy" to mean that you were better than others, they were just being incredibly what, dumb?
A. No. We would never make a claim without showing supporting documentation. So, for example, in the U.S., the doctor could read the label,he could read the FDA approval, and he could see the total span of facts.
Q. I'm not asking about the label and I'm not talking about the FDA
approval. I'm talking about what you've called at various points during this deposition a slogan or a phrase used in regard to Seroquel, and that was unsurpassed efficacy. Are you telling this jury honestly under oath that you were being so incredibly precise in the marketing of Seroquel that "unsurpassed efficacy" really meant that "We were the
same as everybody else"? Is that what you're telling this jury?
A. No. I'm saying that we chose that word to explain the fact that in the studies that we had done, our efficacy was unsurpassed when used in the right patients in the right dose in the right population. You can read a document like this without the context and it would be easy to be misunderstood about the total conclusion for what we say about Seroquel.
